ReWalk Robotics ReStore soft exoskeleton expands clinical trials

Clinical trials for the ReWalk Robotics ReStore soft exoskeleton are expanding to five research centers in the United States. The centers involved in the ReWalk Robotics ReStore trials include the Shirley Ryan AbilityLab (Chicago), Spaulding Rehabilitation Hospital (Boston), the MossRehab Stroke and Neurological Disease Center (Elkins Park, PA), TIRR Memorial Hermann (Houston), and the Kessler Foundation (East Hanover, NJ).

The ReWalk Robotics ReStore soft exoskeleton is expected to launch in the first half of 2019 in Europe and the US. Designed to assist stroke patients, the ReWalk Robotics ReStore is used as a gait therapy solution, providing coordinated plantarflexion and dorsiflexion assistance to a patient’s foot and ankle. ReWalk plans to price the system at under $20,000.

Enrollment for the company’s multi-center study is ongoing.

“We expect that the expansion of our clinical study to these renowned research organizations will bring the ReStore exo-suit closer to CE and FDA clearance,” says ReWalk CEO Larry Jasinski. “The ReStore will offer an immediate and cost-effective solution for the more than three million stroke patients in the U.S. with lower limb disabilities. We are thrilled to be partnering with the most prestigious institutions in the world to bring our product to market.”

“The ReWalk Robotics ReStore is an unobtrusive wearable robotic technology that can seamlessly interact with and enhance everyday clinical care, allowing stroke patients to walk effectively and efficiently,” lead investigator Arun Jayaraman added.

Amended licensing deal for ReWalk Robotics ReStore

ReWalk Robotics also amended its collaborative research and exclusive licensing agreement with Harvard Collage related to the exoskeleton. The new amendments add minor alterations to the licensing agreement, and restructure the language about how Harvard will receive payments from ReWalk Robotics, according to the SEC filing.

The amendments also change the length of the research agreement, now six years from commencement, and alter language related to the research plan. The licensing agreement, originally signed in May, grants ReWalk Robotics an exclusive, worldwide royalty-bearing license for certain patents related to the lightweight soft-suit exoskeleton technologies, according to an SEC filing.

The collaborative agreement was inked on May 1, while the licensing deal was signed on April 1, according to the filing.

The ReWalk Robotics ReStore recently expanded into China thanks to a $20 million investment from Hong Kong-based Timwell Corporation Limited. ReWalk and Timwell affiliate companies will form a joint venture in China to develop, manufacture and market ReWalk’s exoskeletons in China, including Hong Kong and Macau.

ReWalk is looking to expand its international footprint after growing increasingly frustrated with the US market. On its Q4 and Year-End 2017 financial results, ReWalk pointed out slow progress with the US Department of Veterans Affairs (VA) and insurance providers. ReWalk said the VA is expected to purchase eight exoskeletons in 2018, but then added that the “VA continues to be slow to support veterans” in this initiative.